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United States Patent | 6,261,584 |
Peery ,   et al. | July 17, 2001 |
The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.
Inventors: | Peery; John R. (Stanford, CA); Dionne; Keith E. (Menlo Park, CA); Eckenhoff; James B. (Los Altos, CA); Landrau; Felix A. (Punta Gorda, FL); Lautenbach; Scott D. (San Mateo, CA); Magruder; Judy A. (Mountain View, CA); Wright; Jeremy C. (Los Altos, CA) |
Assignee: | Alza Corporation (Mountain View, CA) |
Appl. No.: | 366746 |
Filed: | August 4, 1999 |
Current U.S. Class: | 424/422; 424/423; 424/424; 424/473; 514/772.3; 514/781; 604/891.1 |
Intern'l Class: | A61F 002/00 |
Field of Search: | 424/473,422,423,424,425,426 |
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5057318 | Oct., 1991 | Magruder et al. | 424/438. |
5059423 | Oct., 1991 | Magruder et al. | 424/438. |
5112614 | May., 1992 | Magruder et al. | 424/422. |
5137727 | Aug., 1992 | Eckenhoff | 424/422. |
5213574 | May., 1993 | Tucker | 604/93. |
5213809 | May., 1993 | Wright et al. | 424/473. |
5234692 | Aug., 1993 | Magruder et al. | 424/473. |
5234693 | Aug., 1993 | Magruder et al. | 424/473. |
5308348 | May., 1994 | Balaban et al. | 604/892. |
5413572 | May., 1995 | Wong et al. | 604/892. |
5540665 | Jul., 1996 | Mercado et al. | 604/145. |
Darney, Philip D., "Subdermal Progestin Implant Contraception", Current Opinion in Obst. Gyn., 3:470-476 (1991). BBI Newsletter, "Implantable Infusion Pumps: Technology Poised for Takeoff", 17(12):209-211 (1994). Kildsig, Dane O., et al. "Theoretical Justification of Reciprocal Rate Plots in Studies of Water Vapor Transmission through Films", J. Pharm. Sci., 59(11):1634-1637 (1970). Morgan, P.W., "Structure and Moisture Permeability of Film-Forming Polymers", Ind. Eng. Chem., 45(10):2296-2306 (1953). Materials Engineering, 5(72):38-45 (1972). "Standard Specification for Epoxy Molding Compounds", Ann. Book of ASTM Stds., 8(2):208-211 (1984). Rogers, C.E., et al., "Permeability Valves", Ind. Eng. Chem., 49(11):1933-1936 (1957). |
TABLE 1 Drug Diffusion & Pumping Effective Pump rate Diffusion Water Intrusion Pressure Drop Onifice dia Cross Sec QC.sub.a QD.sub.a Diff/Conv QD.sub.w Qdw delta P (mil) area (mm2) mg/day mg/day QD.sub.a /QC.sub.a mg/day mg/year psi 1 0.00051 0.152 0.0001 0.0005 0 0 1.55800 2 0.00203 0.152 0.0003 0.0018 1.14E-79 4.16E-77 0.09738 3 0.00456 0.152 0.0006 0.0041 4.79E-36 1.75E-33 0.01923 4 0.00811 0.152 0.0011 0.0074 8.89E-21 3.25E-18 0.00609 5 0.01267 0.152 0.0018 0.0115 1.04E-13 3.79E-11 0.00249 6 0.01824 0.152 0.0025 0.0166 7.16E-10 2.61E-07 0.00120 7 0.02483 0.152 0.0034 0.0226 1.48E-07 5.4E-05 0.00065 8 0.03243 0.152 0.0045 0.0295 4.7E-06 0.001715 0.00038 9 0.04105 0.152 0.0057 0.0373 5.04E-05 0.018381 0.00024 10 0.05068 0.152 0.0070 0.0461 0.000275 0.100263 0.00016 11 0.06132 0.152 0.0085 0.0558 0.000964 0.351771 0.00011 12 0.07298 0.152 0.0101 0.0664 0.002504 0.913839 0.00008 13 0.08564 0.152 0.0118 0.0779 0.005263 1.921027 0.00005 14 0.09933 0.152 0.0137 0.0903 0.00949 3.463836 0.00004 15 0.11402 0.152 0.0158 0.1037 0.015269 5.573195 0.00003 16 0.12973 0.152 0.0179 0.1180 0.022535 8.225224 0.00002 17 0.14646 0.152 0.0202 0.1332 0.031114 11.35656 0.00002 18 0.16419 0.152 0.0227 0.1493 0.040772 14.88166 0.00001 19 0.18295 0.152 0.0253 0.1664 0.051253 18.70728 0.00001 20 0.20271 0.152 0.0280 0.1844 0.062309 22.7427 0.00001 Q = 0.38 .mu.l/day C.sub.a = 0.4 mg/.mu.l L = 5 cm D.sub.a = 2.00 E-06 cm.sup.2 /sec .mu. = 5.00 E + 02 cp C.sub.w0 = 0 mg/.mu.l D.sub.w = 6.00 E + 06 cm.sup.2 /sec
Membrane Material 1 month Pebax 25 (Polyamide) 2 month Pebax 22 (Polyamide) 3 month Polyurethane (HP60D) 12 month Pebax 24 (Polyamide)